MAUDE Adverse Event Report: COVIDIEN MICROBORE EXTENSION SET 60IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 60ES

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but has yet to be received.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reports that after the feeding started, infant bed was noted to be wet.When linens were being changed.Feeding noted to be dripping out from feeding tube extension set leaking into bed.

Manufacturer Narrative

The device history record was reviewed and indicated that product was released meeting all quality standard requirements.One sample was returned to the plant for the investigation.After performing a visual evaluation, the condition reported was confirmed, the extension set was leaking.A definitive root cause could not be determined at this time.During the manufacturing process a 100% leakage test is performed on cap and step connectors and dust cover assembly, at present the quality inspection in the occlusion and leakage tests is sampled at a reduced level.A sampling plan change has been made at a rigorous level to contain possible leaks and occlusions in extension kits.

• Brand Name: MICROBORE EXTENSION SET 60IN
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8583920
• MDR Text Key: 144247808
• Report Number: 9612030-2019-02165
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 60ES
• Device Catalogue Number: 60ES
• Device Lot Number: 1905021464
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1